MalfunctionJOS
NEEDLE ELECTRODE
Received May 5, 2014 · Event occurred Mar 18, 2014
Report 1717344-2014-00394 · MDR key 3945244
Device
Product problems
- Fire
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT WHILE COAGULATING, A FLAME WAS NOTICED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO INJURIES TO THE PT. THE SITE REPORTED THAT BETADINE ALCOHOL HAD BEEN USED.
Additional Manufacturer Narrative
(B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.